ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.

Device Description

The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy. The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat. The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated. For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user. The ATMOS Scope is delivered in a non-sterile condition.

AI/ML Overview

The provided text describes the ATMOS Scope, a flexible nasopharyngo laryngoscope, and its equivalence to a predicate device (Schoelly CMOS Video Nasopharyngoscope System K143673). However, the document does not contain information typically associated with acceptance criteria and a study design for evaluating the diagnostic performance of a medical device using an AI component.

Instead, the provided text focuses on demonstrating substantial equivalence through comparisons of technical characteristics and various non-clinical performance tests. These tests are primarily related to safety, functionality, and manufacturing compliance, rather than diagnostic accuracy or effectiveness in a clinical context that would require a human-in-the-loop or standalone AI performance study.

Therefore, I cannot directly answer your questions in the requested format as the provided document does not include such a study or information.

Here's what I can extract based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for diagnostic performance or reported performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various technical parameters and confirms successful testing against standards.

Acceptance Criteria Category	Reported Device Performance Summary
Indications for Use	"ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor." (Identical to predicate)
Design	Flexible and steerable fiberoptic endoscope for diagnostic purposes (Identical to predicate)
Material	Handle: aluminum; Insertion tube: PEEK, FKM, TPU, sapphire glass (Identical to predicate)
Chip-on-Tip	CMOS image sensor at the tip of the insertion tube (Identical to predicate)
Illumination	LED (2 LEDs) (Identical to predicate)
Deflection	2 x 135° (Identical to predicate)
Weight	0.4 kg (Identical to predicate)
USB Connection	Yes (Identical to predicate, though direct connection to PC vs. via CCU is a difference)
Focus Range	6 - 60 mm (Identical to predicate)
Delivery Status	Non-sterile (Identical to predicate)
Image Sensor Resolution	1280 x 800 pixels (Higher than predicate's 328 x 250 pixels); Justification: provides optimized view, not a negative impact on safety/effectiveness.
Field of view	90° (Larger than predicate's 85°); Justification: provides optimized view, not a negative impact on safety/effectiveness.
Stroboscopy	Not supported (Removed feature from predicate due to patient complaints).
Sterilization	Validated for Low-Temperature Hydrogen Peroxide Gas Sterilization and SYSTEM 1E® Liquid Chemical Sterilant Processing System (differs from predicate's ethylene oxide); Validation tests performed according to FDA recognized standards.
Reprocessing	Manual cleaning with MetriZyme™ or Cidezyme, and manual high-level disinfection with CIDEX® OPA (differs from predicate's listed solutions); Validation performed by AAMI TIR 30: 2011 and ASTM E 1837-96 (2014).
Human Factors	Successfully tested regarding dimensions (length, diameter, deflection/angle) and requirements for basic safety and essential performance of endoscopic equipment per IEC 60601-2-18. Ergonmics of patient and user interfaces are equivalent to the predicate device.
Optical Performance & Photobiological Safety	Evaluation per IEC 62471:2006, LEDs classified in risk group 2. Measurements prove photobiological safety and no risk/hazard from light source.
Biocompatibility	Evaluation performed to comply with ISO 10993-1:2018 and FDA Guidance Documents. Effectiveness confirmed.
Electrical Safety & EMC	Tests performed per IEC 60601-1:2005 (Electrical Safety) and IEC 60601-1-2 Edition 4.0 2014-02 (EMC). All risk-based requirements and acceptance criteria were defined and met.
Software V&V	Embedded software does not provide support for basic safety or essential performance. Failure does not lead to risk. All firmware functions validated; requirements traceability matrix documented. USB connection checked for configuration, device name, and live image broadcast. All firmware tests passed successfully.
Labeling	In compliance with ANSI ISO 15223-1 3rd edition 2016-11-01.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical performance and safety testing. There is no mention of a test set for diagnostic performance or data provenance for such a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a test set for diagnostic performance or experts establishing ground truth. The device provides "visualization via a monitor" for "visual diagnostics by the user," implying human interpretation, but no study is detailed to quantify this diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No diagnostic performance test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The ATMOS Scope is a visualization device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a direct visualization tool. There is no AI algorithm component described for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No diagnostic performance study requiring ground truth is described.

8. The sample size for the training set

Not applicable. There is no mention of an AI component or a training set for machine learning.

9. How the ground truth for the training set was established

Not applicable. No AI component or training set is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 3, 2023

ATMOS MedizinTechnik GmbH & Co. KG Reinhold Storch Manager Projects & Technical Editing ENT/GYNE/FEES Ludwig-Kegel-Str. 16 Lenzkirch, BW 79853 Germany

Re: K232015

Trade/Device Name: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: April 7, 2023 Received: July 6, 2023

Dear Reinhold Storch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Joyce C. Lin -S" in a simple, sans-serif font. The text is black against a background that appears to be white. The letters are clear and legible, with consistent spacing between them. The overall impression is clean and professional.

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232015

Device Name

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for ATMOS MedizinTechnik. The logo features the word "ATMOS" in a bold, sans-serif font, arranged in an arc shape. Below the word "ATMOS" is the word "MedizinTechnik" in a smaller, sans-serif font. The color of the logo is blue.

510(k) Summary

Submitter:

Contact Person:

ATMOS MedizinTechnik GmbH & Co. KG

Dr. Reinhold Storch ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: + 49 7653 689-647 Email: regulatory@atmosmed.de

ATMOS Scope (507.7000.0) ATMOS Scope Pro (507.7050.0) ATMOS Scope iPrime (507.7060.0)

21 CFR 874.4760

Ear, Nose & Throat

K232015

Class II

EOB

Nasopharyngoscope (Flexible Or Rigid)

Date Prepared:

28.07.2023

Device

Name of Device:

Classification Name: Regulation: 510(k): Device Classification: Medical Specialty: Device Product Code:

Predicate device

Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): Device Product Code:

Schoelly Fiberoptic GmbH Schoelly CMOS Video Nasopharyngoscope System K143673 EOB

Device Description

The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy.

The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat.

The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated.

For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user.

The ATMOS Scope is delivered in a non-sterile condition.

Indication for use

Intended patient target group

Patients for whom an endoscopic examination is generally indicated. The use of the device also depends on the patient's general condition and must therefore be critically evaluated by the responsible physician before each use.

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Image /page/4/Picture/1 description: The image shows the logo for ATMOS MedizinTechnik. The logo features the word "ATMOS" in a bold, sans-serif font, with the letters arranged in a slightly curved manner. The word "MedizinTechnik" is written in a smaller, sans-serif font below the word "ATMOS".

Comparison of technological characteristics with the predicate device

The following characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence:

Similarities
Feature	Subject Device	Predicate Device
	ATMOS Scope	K143673
Indications for Use	ATMOS Scope is used forendoscopic diagnosis withinthe nasal lumens and airwayanatomy and is intended toprovide visualization via amonitor. The ATMOS Scopemay only be used by personswith an appropriate medicalqualification and who areacquainted with therhino/laryngoscopic technique.	The Schoelly CMOS VideoNasopharyngoscope Systemmay only be used by personswith appropriate medicalqualifications and who areacquainted with therhino/laryngoscopic technique.The endoscope is used forendoscopic diagnosis withinthe nasal lumens and airwayanatomy and is intended toprovide visualization via avideo monitor.
Design	Flexible and steerablefiberoptic endoscope fordiagnostic purposes	Flexible and steerablefiberoptic endoscope fordiagnostic purposes
Material	The handle is made ofaluminum (hard anodized andcoated) with a multifunctionalsurface coating. The insertiontube is made of PEEK, FKM,TPU, and sapphire glass.	The handle is made ofaluminium (hard anodized andcoated) with a multifunctionalsurface coating. The insertiontube is made of PEEK, FKM,TPU, and sapphire glass.
Chip-on-Tip	Chip-on-Tip technologyintegrated: CMOS imagesensor at the tip of the insertiontube	Chip-on-Tip technologyintegrated: CMOS imagesensor at the tip of the insertiontube
Lightning	LED (2 LEDs)	LED (2 LEDs)
Deflection	2 x 135°	2 x 135°
Weight	0,4 kg	0,4 kg
USB Connection	Yes	Yes
Focus Range	6 - 60 mm	6 – 60 mm
Delivery Status (Sterilization)	None-sterile	None-sterile

Table 1 Similarities between a subject device and predicate device

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510(k) Submission – ATMOS Scope 510(k) Summary

K232015

Image /page/5/Picture/1 description: The image contains the logo for ATMOS MedizinTechnik. The logo features the word "ATMOS" in a bold, sans-serif font, with the letters arranged in a slightly curved manner. Above the word is a blue circular shape that partially encloses the text. Below the word "ATMOS" is the word "MedizinTechnik" in a smaller, sans-serif font.

Differences
Feature	Subject DeviceATMOS Scope	Predicate DeviceK143673	Justification
ImageSensorResolution ofthe imagesensor(Pixel)	1/14.25" CMOS1280 x 800800 x 800 (640.000)	1/18" CMOS328 x 250328 x 250 (82.000)	CMOS sensors areinstalled as image sensorsfor both subject device aswell as predicate device.These provide images ofdifferent resolutions. Incomparison with thepredicate device, theeffective resolution of theATMOS Scope is higher(resulting from thecombination of its slightlylarger field of view and thehigher pixel number of itsimage sensor). The higherresolution provides anoptimized view of theanatomy. Therefore, theaspect "safety andeffectiveness" is notimpacted negatively duethe different imageresolution with the ATMOSScope.
Connectionto PC	Connection to PC via USB(control and video signal),control of LEDs and buttons.	The device handle shall beconnected to the CCU.CCU can be connected tothe PC via USB (controlfunctions and video signal),monitor via s-video (videosignal), and stroboscope.Internal control of LEDs andbutton action.	Both, subject device aswell as predicate deviceare using a USBconnector. While K143673requires a control unit tobe connected, ATMOSScopes can be connecteddirectly to the PC. Thisdoes not change the riskfor the patient.
Field of view	90°	85°	In comparison with thepredicate device, theeffective resolution of theATMOS Scope is higher(resulting from thecombination of its slightlylarger field of view and thehigher pixel number of itsimage sensor). The largerfield of view provides anoptimized view of theanatomy. Therefore, theaspect "safety andeffectiveness" is notimpacted negatively duethe difference in the field ofview with the ATMOSScope.
Stroboscopy	Not supporting stroboscopy	stroboscopy	This feature removed fromsubject device due topatient complaints inK143673.
Sterilization(optional)	The ATMOS Scope withattachment for pressurecompensation can be sterilizedby using a Low-TemperatureHydrogen Peroxide GasSterilization Method. Thissterilization process can beoptionally conducted after oneof the reprocessing methods.The following parameter of thesterilization processes arevalidated: H2O2 Concentration[mg/L]: 16Plasma power [W]: 350WCycle Duration [min]: 58Deep Vacuum [mTorr]: 275The second validatedsterilization method isperformed in the SYSTEM 1E®Liquid Chemical SterilantProcessing System withstandard liquid chemicalsterilization (LCS) cycles usingS40® Sterilant.	Flexible Schoelly endoscopewith air-exhaust can also begas sterilized using ethyleneoxideSpecification: Gas mixture6% Eto, 94% CO2Temperature 131°F+/-5°F,55°C+/-2°CRelative air humidity 40-90%Pressure (overpressure),17bar (17kpa)Exposure time 120 mins	Validation tests wereperformed according toFDA recognized standardsand Guidance to provideperformance data insupport of the substantialequivalence determination:
Reprocessing	The manual reprocessingmethod consists of the manualcleaning process by using theDual enzymatic cleaningdetergent MetriZymeTM(MetriSPONGE; companyMetrex) or Cidezyme (ASP®)and the manual high-leveldisinfection process by usingthe ready-to-use solutionCIDEX® OPA (ASP®) for 18minutes at a minimumtemperature of 20°C.	Place the endoscope and theunscrewed parts in a suitabledisinfection solution (whichcan also double up as acleaning solution usedshould be permitted by themanufacturer for such use,Material compatibility releaseexist for the followingdisinfectants• Gigasept FF, Schulke &Maye GmbH• Lysetol FF• Helipur HplusN, B BraunMedical AG• Cidex, Johnson & Johnson	Validation tests wereperformed according toFDA recognized standardsand Guidance to provideperformance data insupport of the substantialequivalence determination

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510(k) Submission - ATMOS Scope 510(k) Summary K232015

Image /page/6/Picture/1 description: The image shows the logo for ATMOS MedizinTechnik. The logo consists of the word "ATMOS" in blue, with the "A" stylized to have a point at the top. The word "MedizinTechnik" is written in black below the logo. The logo is surrounded by a blue circle.

Table 2 Differences between a subject device and predicate device

The technological differences do not raise different questions of safety and effectiveness.

Performance data

The following performance data were provided in support of the substantial equivalence determination.

Human factors testing

The human factors testing is conducted regarding to the dimensions of the applied part (length and diameter and deflection/angle measurement) and the particular requirements for the basic safety and essential performance of endoscopic equipment according to the standard IEC 60601-2-18 were successfully tested.

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Image /page/7/Picture/1 description: The image shows the logo for Atmos MedizinTechnik. The logo consists of the word "ATMOS" in blue, with the letters arranged in a semi-circular shape. Below the word "ATMOS" is the word "MedizinTechnik" in black, with the first letter of each word capitalized.

Optical performance test and photobiological safety of lamp system

An evaluation according to the standard IEC 62471:2006 was conducted and the used LEDs were classified in risk group 2. Additionally, due to the integrated optical light range of the LED is limited. Summarized all aspects considered and the measurements prove that the photobiological safety of the ATMOS Scope product is guaranteed and there is no risk as well as no hazard from the light source.

Sterilization validation

Both sterilization processes were validated by EN ISO 14937 (Annex D), AAMI TIR 12, and ANSI/AAMI ST79 and can be optionally conducted after one of the reprocessing methods. First sterilization process is using a Low-Temperature Hydrogen Peroxide Gas Sterilization Method. The second validated sterilization method is performed in the SYSTEM 1E® Liquid Chemical Sterilant Processing System with standard liquid chemical sterilization (LCS) cycles using S40® Sterilant.

Biocompatibility evaluation

Biocompatibility evaluation of subject device ATMOS Scope was performed to comply with the specifications as per standard ISO 10993-1:2018 as well as the FDA Guidance Documents and the effectiveness of the biocompatibility of the ATMOS Scope.

Reprocessing Testing

The reprocessing method consists of a cleaning process conducted and validated by AAMI TIR 30: 2011 and a high-level disinfection process conducted and validated by ASTM E 1837-96 (2014). The manual cleaning process can be conducted by using the Dual enzymatic cleaning detergent MetriZymeTM (MetriSPONGE; company Metrex) or Cidezyme (ASP®) and the manual high-level disinfection process by using the ready-to-use solution CIDEX® OPA (ASP®).

Electrical safety and electromagnetic compatibility (EMC)

To ensure safe operation of ATMOS Scope, tests were performed according to IEC 60601-1:2005. All clauses of this standard are evaluated and assessed in the corresponding risk assessment file. To measure the ability of ATMOS Scope to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment, Electromagnetic Compatibility Test according to IEC 60601-1-2 Edition 4.0 2014-02 was performed. With a risk-based approach required tests and acceptance criteria were defined.

Software Verification and Validation

Embedded software does not provide support for basic safety or essential performance. Failure of the software does not lead to a risk, therefore PEMS (IEC 60601-1 section 14) does not apply. Every firmware function was validated, and the requirements traceability matrix was documented to prove that requirements have been fulfilled.

Digital image after generation can be displayed on a connected PC with any video software. Due to this requirement the USB connection was checked regarding their configuration, USB device name "ATMOS Scope" and used live image broadcast according to the USB Video Device Class Specification. Summarized all tests regarding to the firmware were passed successfully.

Labelling

All labeling and documentation associated with the ATMOS Scope are in compliance with 5-117 AAM ANSI ISO 15223-1 3rd edition 2016-11-01, Medical Devices - Symbols To Be Used With Medical Devices Labels, Labeling, And Information To Be Supplied - Part 1: General Requirements. This is not subject to test requirements and no test report is provided.

Conclusion

Non-clinical, simulated use und human factors testing were performed to compare the performance of the subject device and the predicate device using identical inputs. Testing results demonstrated that the

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Image /page/8/Picture/1 description: The image shows the logo for ATMOS Medizintechnik. The logo features the word "ATMOS" in a bold, sans-serif font, arranged in an arc shape. A blue circle surrounds the word "ATMOS". Below the word "ATMOS" is the word "MedizinTechnik" in a smaller, sans-serif font.

performance of the subject device is equivalent to the predicate device for each software, electrical and mechanical design specification.

A risk analysis was completed, and risk controls were implemented. Human factors testing was conducted to demonstrate that the ergonomics of patient and user interfaces for the subject device are equivalent to the predicate device.

Based upon the intended use, descriptive information, and performance evaluation provided the ATMOS Scope is substantially equivalent to the currently marketed predicate device K143673.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.